Food and Drug Administration

agency of the US Department of Health and Human Services

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Winder Laboratories recalls multivitamins over low vitamin D levels
science Mar 14, 2026, 2:57 PM
Winder Laboratories recalls multivitamins over low vitamin D levels
  • A chewable multivitamin recall has been initiated across 25 states due to low levels of vitamin D.
  • The FDA inspected products by Winder Laboratories, LLC, leading to a voluntary recall classification of Class III.
  • Consumers are advised to check specific lot information to identify affected products and take corrective actions.
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FDA revolutionizes drug safety monitoring with AI-driven platform
technology Mar 11, 2026, 11:41 AM
FDA revolutionizes drug safety monitoring with AI-driven platform
  • The FDA has launched the AI-powered Adverse Event Monitoring System (AEMS) to improve health reporting.
  • AEMS consolidates outdated systems used for processing millions of adverse event reports.
  • The initiative is expected to save taxpayers approximately $120 million over the next five years.
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science Mar 10, 2026, 7:12 PM
FDA rejects generic autism drug despite pressure from Trump administration
  • The FDA made a careful decision to reject a generic autism drug due to insufficient evidence.
  • This decision follows pressures from the Trump administration which sought faster drug approvals.
  • The rejection emphasizes the importance of scientific data in regulatory decisions regarding autism treatment.
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Senator Johnson probes FDA for rejecting key treatments for rare diseases
politics Mar 10, 2026, 10:12 AM
Senator Johnson probes FDA for rejecting key treatments for rare diseases
  • Senator Ron Johnson is investigating the FDA due to increasing denials of drug treatments for rare diseases.
  • The FDA has reportedly rejected about 20 drug applications aimed at treating rare conditions in recent months.
  • Johnson is seeking transparency and may require FDA officials to defend their decisions before Congress.
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FDA recalls clams and oysters over norovirus fears
science Mar 9, 2026, 10:27 PM
FDA recalls clams and oysters over norovirus fears
  • The FDA issued a recall for clams and raw oysters due to concerns over possible norovirus contamination.
  • The affected shellfish were distributed in nine states including Arizona, California, and Florida.
  • Consumers are advised not to eat the recalled products, emphasizing that shellfish can carry pathogens that lead to serious illness.
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FDA vaccine chief Dr. Vinay Prasad resigns amid controversy
politics Mar 6, 2026, 11:54 PM
FDA vaccine chief Dr. Vinay Prasad resigns amid controversy
  • Dr. Vinay Prasad will leave his position at the FDA's Center for Biologics Evaluation and Research by the end of April, according to an agency spokesperson.
  • His tenure has been characterized by criticisms regarding vaccine approvals and controversial statements regarding COVID-19 vaccines.
  • The agency is expected to appoint a successor before his departure, marking a significant transition in leadership.
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FDA issues warning over allergen concerns in recalled almonds
science Mar 5, 2026, 4:15 PM
FDA issues warning over allergen concerns in recalled almonds
  • Bader Enterprises Inc. recalled Premium Food Jordan Almonds due to undeclared allergens and certified color additives.
  • The FDA classified the recall as Class II, indicating potential health risks linked to allergic reactions.
  • Consumers are advised to check product labels carefully and remain informed about food safety recalls.
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science Feb 26, 2026, 4:37 PM
Oregon Potato Company recalls thousands of pounds of blueberries over listeria risk
  • Frozen blueberries from Oregon Potato Company were recalled due to potential listeria contamination.
  • The FDA classified the recall as a Class I, indicating serious health risks.
  • Consumers are urged to discard affected products or return them for refunds.
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FDA warns of fatal listeria risk in cream cheese and tofu recall
science Feb 24, 2026, 5:13 PM
FDA warns of fatal listeria risk in cream cheese and tofu recall
  • The U.S. Food and Drug Administration announced a recall of multiple cream cheese and tofu flavors due to listeria contamination.
  • The affected products were distributed in New York City, particularly in Brooklyn, Queens, and the Bronx.
  • Consumers are advised to return the products for a refund and seek medical help if experiencing symptoms.
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RFK Jr. and Kessler fight against ultra-processed food's GRAS status
politics Feb 21, 2026, 10:00 AM
RFK Jr. and Kessler fight against ultra-processed food's GRAS status
  • RFK Jr. and Dr. Kessler are advocating for health reforms targeting ultra-processed foods.
  • They criticize the GRAS designation allowing manufacturers to self-regulate food safety.
  • Their campaign highlights the need for a cultural shift towards healthier whole-food choices.
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FDA drops two-study requirement for new drug approvals
science Feb 18, 2026, 11:00 PM
FDA drops two-study requirement for new drug approvals
  • The FDA has announced it will now require only one study for new drug approvals instead of two.
  • This change reflects modern advances in drug research and aims to reduce bureaucracy.
  • Experts predict this new approach will lead to a significant increase in drug development.
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Former FDA chief warns ultra-processed foods harm American health
science Feb 16, 2026, 11:02 AM
Former FDA chief warns ultra-processed foods harm American health
  • Dr. David Kessler warns that ultra-processed foods categorized as GRAS are detrimental to health.
  • He highlights rising rates of diet-related diseases linked to these foods.
  • Kessler advocates for revoking the GRAS status of certain substances to protect public health.
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FDA rejects Moderna's flu vaccine application over trial design issues
science Feb 11, 2026, 11:37 PM
FDA rejects Moderna's flu vaccine application over trial design issues
  • The FDA denied Moderna's application due to concerns over clinical trial design that risked patient safety.
  • Moderna used a flu vaccine not recommended by health authorities, raising allegations of trying to enhance its own product's efficacy.
  • The incident reflects broader issues of trust and clarity in regulatory practices within the vaccine development industry.
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science Feb 11, 2026, 12:15 AM
FDA refuses to consider moderna's mRNA flu vaccine application
  • Moderna received a refusal-to-file letter from the FDA regarding its new mRNA flu vaccine application.
  • The FDA raised concerns about the conduct of Moderna's 40,000-person clinical trial, specifically its comparison to the standard of care.
  • This refusal reflects heightened scrutiny of mRNA vaccines by the FDA under Health Secretary Robert F. Kennedy Jr.
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AI technology linked to numerous surgical complications and malfunction reports
technology Feb 9, 2026, 3:36 PM
AI technology linked to numerous surgical complications and malfunction reports
  • Since the FDA authorized AI medical devices, there have been unconfirmed reports of at least 100 adverse events.
  • Companies such as Integra LifeSciences insist that reports do not establish a direct link between their technology and patient injuries.
  • Increased adoption of AI in medical devices is causing concerns regarding safety and efficacy in surgical procedures.
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Keurig coffee pod recall sparks health concerns over caffeine content
science Jan 27, 2026, 12:09 PM
Keurig coffee pod recall sparks health concerns over caffeine content
  • Over 80,000 Keurig coffee pods were recalled due to incorrect labeling indicating decaf but potentially containing caffeine.
  • The recall was categorized as a Class II health risk by the FDA, indicating possible temporary adverse health effects.
  • Consumers are advised to discard the recalled product or return it for a refund, highlighting the need for accurate product labeling.
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Spring & Mulberry recalls eight chocolate products over salmonella fears
lifestyle Jan 15, 2026, 9:45 PM
Spring & Mulberry recalls eight chocolate products over salmonella fears
  • Spring & Mulberry has expanded its chocolate recall to eight different products due to salmonella fears.
  • The recall includes flavors such as Earl Grey, Lavender Rose, and Mango Chili, among others.
  • Customers are advised to dispose of the affected products and seek refunds or replacements.
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FDA approves Wegovy pill for effective weight loss treatment
science Dec 22, 2025, 7:42 PM
FDA approves Wegovy pill for effective weight loss treatment
  • The FDA approved the first oral version of Wegovy, a GLP-1 drug for weight loss.
  • In clinical trials, participants experienced significant weight loss, averaging 16.6% body weight reduction.
  • The approval of the Wegovy pill provides a new option for patients seeking effective weight management solutions.
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FDA's lax regulation on tacrolimus contributes to patient death
science Dec 19, 2025, 12:30 PM
FDA's lax regulation on tacrolimus contributes to patient death
  • Hannah Goetz, a lung transplant patient, relied on tacrolimus for her health, but faced issues with the generic form of the drug.
  • Concerns about the quality of tacrolimus generics arose, leading some hospitals to prefer the brand-name version.
  • Hannah's death raises critical questions about the FDA's role in ensuring drug safety and effectiveness.
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Retailers fail to act on infant formula recall linked to botulism outbreak
society Dec 15, 2025, 11:04 PM
Retailers fail to act on infant formula recall linked to botulism outbreak
  • The FDA recalled ByHeart infant formula in November 2023 due to an outbreak of infant botulism.
  • Major retailers including Walmart, Target, Kroger, and Albertsons continued to sell the recalled formula despite being notified.
  • The failure to comply with the recall has raised concerns regarding infant safety and the effectiveness of the food supply chain.
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FDA admits COVID vaccines caused deaths of children
science Dec 11, 2025, 6:10 PM
FDA admits COVID vaccines caused deaths of children
  • An FDA memo has indicated a link between COVID vaccinations and the deaths of at least 10 children.
  • The memo has been met with severe criticism from public health officials who argue it undermines vaccine credibility.
  • This revelation has led to heightened scrutiny of COVID vaccine policies regarding children, sparking a renewed debate over their necessity.
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FDA proposes new sunscreen ingredient to enhance skin protection
science Dec 11, 2025, 2:00 PM
FDA proposes new sunscreen ingredient to enhance skin protection
  • The FDA proposed making bemotrizinol available as a new sunscreen ingredient in the US.
  • Bemotrizinol has been used in Europe and Asia, providing better protection against UVA and UVB rays.
  • This proposal marks a significant advancement in the US sunscreen industry and aims to enhance consumer options.
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FDA chief acknowledges moral duty to disclose COVID-19 vaccine risks
science Dec 10, 2025, 1:00 AM
FDA chief acknowledges moral duty to disclose COVID-19 vaccine risks
  • Marty Makary revealed that internal FDA data indicates a possible connection between COVID-19 vaccine and child deaths.
  • The FDA is reportedly considering adding a black box warning to COVID-19 vaccines to inform about potential risks.
  • The controversy surrounding these findings raises serious questions about vaccine mandates and public trust in health authorities.
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FDA scrutinizes RSV drugs for infants amid vaccination concerns
society Dec 9, 2025, 6:32 PM
FDA scrutinizes RSV drugs for infants amid vaccination concerns
  • The FDA has begun a review of two approved drugs for infants to protect against RSV, Beyfortus and Enflonsia.
  • No safety issues have been reported with the drugs, which are based on monoclonal antibody technology.
  • The safety review occurs against a backdrop of changed vaccination recommendations led by Health Secretary Robert F. Kennedy Jr., raising concerns among health experts.
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FDA's claims of COVID vaccines causing child deaths lack evidence
science Dec 6, 2025, 6:17 PM
FDA's claims of COVID vaccines causing child deaths lack evidence
  • The FDA is attempting to change vaccine safety testing procedures based on claims linking mRNA vaccines to child deaths.
  • Evidence connecting COVID-19 vaccines to these deaths has not been substantiated, with many deaths often misattributed.
  • Comparing the illness risks to vaccine side effects emphasizes that COVID-19 poses a far greater risk to children than the vaccines do.
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science Dec 4, 2025, 11:45 PM
FDA warns of faulty glucose monitors linked to deaths
  • The FDA issued a warning about certain glucose monitor sensors manufactured by Abbott Diabetes Care.
  • These faulty sensors have been associated with seven deaths and over 700 injuries globally.
  • Consumers are advised to stop using these devices to prevent serious health risks.
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FDA alleges COVID-19 vaccines caused child deaths without evidence
science Dec 4, 2025, 6:43 PM
FDA alleges COVID-19 vaccines caused child deaths without evidence
  • The FDA alleges that mRNA-based COVID-19 vaccines have caused the deaths of at least 10 children.
  • Currently, over 800 children in the U.S. died from COVID-19 between August 2021 and July 2022, while very few deaths linked to vaccines have been confirmed.
  • More reliable safety assessments are needed to accurately weigh vaccines' risks against the potential harm posed by the diseases they prevent.
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Costco recalls salads after plastic contamination risk
science Dec 4, 2025, 10:56 AM
Costco recalls salads after plastic contamination risk
  • Costco recalled two salad products due to the discovery of plastic contamination.
  • The affected products were sold in 34 U.S. states and Puerto Rico.
  • Consumers are advised to return the products for a full refund, emphasizing safety.
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New glasses approved to slow myopia progression in children
society Dec 1, 2025, 1:00 AM
New glasses approved to slow myopia progression in children
  • The FDA approved new glasses in September that slow myopia progression in children.
  • Studies indicate rising myopia rates are linked to increased screen time and close-up activities.
  • The new lenses may revolutionize pediatric eye care by preventing severe long-term consequences.
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Paradromics secures FDA approval to test brain chip for speech restoration
science Nov 27, 2025, 11:49 AM
Paradromics secures FDA approval to test brain chip for speech restoration
  • Paradromics, a U.S. neurotechnology startup, received FDA approval for its first human trial.
  • The trial will test the Connexus BCI device designed for restoring speech through neural signals.
  • This breakthrough could notably improve communication for individuals with severe motor impairments.
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FDA warns of fatal risks in Sarepta gene therapy for muscular dystrophy
science Nov 14, 2025, 9:14 PM
FDA warns of fatal risks in Sarepta gene therapy for muscular dystrophy
  • The FDA announced a new boxed warning for Elevidys due to the risk of liver failure.
  • The therapy's use is now limited to patients who are 4 years old and can walk.
  • These changes follow two reported deaths linked to the gene therapy, affecting Sarepta's business.
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